Kerastase Paris Symbiose Antidandruff by L'Oreal USA Products Inc / L'OREAL USA, INC Drug Facts

Kerastase Paris Symbiose Antidandruff by

Drug Labeling and Warnings

Kerastase Paris Symbiose Antidandruff by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'OREAL USA, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KERASTASE PARIS SYMBIOSE ANTIDANDRUFF- pyrithione zinc shampoo 
L'Oreal USA Products Inc

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Drug Facts

Active ingredient

Pyrithione zinc 1%

Purpose

Antidandruff

Uses

• helps eliminate the symptoms of dandruff

Warnings

For external use only

When using this product

avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

condition worsens or does not improve after regular use of this product as directed

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• for best results use at least twice a week or as directed by a doctor 
• apply to hair
• massage
• rinse

Inactive ingredients

water, cocamidopropyl betaine, disodium laureth sulfosuccinate, sodium lauryl sulfoacetate, decyl glucoside, sodium lauroyl sarcosinate, glycol distearate, sodium chloride, coco-betaine, fragrance, amodimethicone, citric acid, PPG-5-ceteth-20, sodium hydroxide, acrylates copolymer, sodium benzoate, carbomer, PEG-55 propylene glycol oleate, propylene glycol, polyquaternium-39, limonene, squalane, menthol, glycerin, benzoic acid, trideceth-6, sodium polynaphthalenesulfonate, benzyl salicylate, salicylic acid, benzyl alcohol, linalool, citronellol, citral, geraniol, cetrimonium chloride, cellulose gum, artemisia umbelliformis flower extract, tetrasodium EDTA, methylisothiazolinone, potassium sorbate

KERASTASE PARIS SYMBIOSE ANTIDANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-871
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCO-BETAINE (UNII: 03DH2IZ3FY)
AMODIMETHICONE (1300 CST) (UNII: 3V7U636DWN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PPG-5-CETETH-20 (UNII: 4AAN25P8P4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PEG-55 PROPYLENE GLYCOL OLEATE (UNII: 7RDE7PJS40)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYQUATERNIUM-39 (35/35/30 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1500000 MW) (UNII: EOD3UE785A)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
SQUALANE (UNII: GW89575KF9)
MENTHOL (UNII: L7T10EIP3A)
GLYCERIN (UNII: PDC6A3C0OX)
BENZOIC ACID (UNII: 8SKN0B0MIM)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
SALICYLIC ACID (UNII: O414PZ4LPZ)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
CITRAL (UNII: T7EU0O9VPP)
GERANIOL (UNII: L837108USY)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
ARTEMISIA UMBELLIFORMIS FLOWER (UNII: 91OLL9AJ7D)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-871-01	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/12/2022	01/31/2025
2	NDC: 49967-871-02	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/12/2022	04/30/2025
3	NDC: 49967-871-03	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/12/2022	01/31/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	12/12/2022	04/30/2025

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA, INC		960317444	manufacture(49967-871) , pack(49967-871)

Revised: 6/2024

Document Id: fc78c443-6fe5-4763-8fea-fb5fc465007c

34390-5

Set id: 61f2c72a-7ddb-418e-ae22-185248fc896d

Version: 5

Effective Time: 20240624